Patient demographics
Patient Initials
text
Participating Group
text
Medical Record Number
text
Study Number Participating Group
text
Institution Name
text
Trial subject ID Participating Group
text
Adverse Event Expedited Reporting System filed?
AdverseEventReportInd-3
boolean
Expected Adverse Events
CTC Adverse Event Term
text
MedDRACode
text
MedDRACode
text
CTC Adverse Event Term
text
CTC Adverse Event Grade
float
CTC Adverse Event Grade
float
CTC Adverse Event Attribution Category
text
CTC Adverse Event Attribution Category
text
Form completed by
Person Completing Form
text
Form Completion Date
date